Cleared Special

K182067 - PleuraFlow System with FlowGlide Extra Drainage Length (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182067 · Clearflow, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
13d
Days
Class 2
Risk

K182067 is an FDA 510(k) clearance for the PleuraFlow System with FlowGlide Extra Drainage Length. Classified as Wound Drain Catheter System (product code OTK), Class II - Special Controls.

Submitted by Clearflow, Inc. (Anaheim, US). The FDA issued a Cleared decision on August 14, 2018 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Clearflow, Inc. devices

Submission Details

510(k) Number K182067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date August 14, 2018
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 114d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTK Wound Drain Catheter System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Use As An Adjunctive Device During Open Surgical Procedures In Order To Prevent Fluid Accumulation Within The Operative Site After Closure Of The Surgical Wound. The Device Is Indicated For Use In Thoracic Surgical Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.